SPIRACTIN Tablet Ref.[50295] Active ingredients: Spironolactone

Source: Marketing Authorisation Holder Revision Year: 2022 Publisher: Alphapharm Pty Ltd trading as Viatris, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.viatris.com.au, Phone: 1800 274 276

Product name and form

SPIRACTIN Spironolactone.

Pharmaceutical Form
25 mg tablet: 7 mm pale orange, normal convex, peppermint flavoured, marked “SP” breakline “1” on one side, “α” symbol on the reverse. 100 mg tablet: 11 mm pale orange, normal convex, peppermint flavoured, marked “SP” breakline “2” on one side, “α” symbol on the reverse.

Qualitative and quantitative composition

Each 25 mg tablet contains 25 mg of spironolactone as the active ingredient.

Each 100 mg tablet contains 100 mg of spironolactone as the active ingredient.

Excipients with known effect: sugars as lactose and trace quantities of galactose and sulfites.

For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.

Chemical Structure

Chemical name: 7α-acetylthio-3-oxo-17α-pregn-4-ene-21,17β-carbolactone

Structural formula:

Molecular formula: C₂₄H₃₂O₄S

Molecular weight: 416.6

CAS Number: 52-01-7

Active Ingredient	Description
Spironolactone	Spironolactone, as a competitive aldosterone antagonist, increases sodium excretion whilst reducing potassium loss at the distal renal tubule. It has a gradual and prolonged action.

List of Excipients
25 mg and 100 mg tablets contain lactose monohydrate, microcrystalline cellulose, maize starch, polysorbate 80, povidone, sodium starch glycollate, purified talc, magnesium stearate, peppermint oil, quinoline yellow, erythrosine and sunset yellow FCF.

Pack sizes and marketing

Container Type: HDPE bottles with PP cap – Child Resistant Closure.

Pack Size: 100 tablets.

Australian Register of Therapeutic Goods (ARTG)

AUST R 46689 – SPIRACTIN 25 spironolactone 25mg tablet bottle.

AUST R 46691 – SPIRACTIN 100 spironolactone 100mg tablet bottle.

Marketing authorization holder

Alphapharm Pty Ltd trading as Viatris, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.viatris.com.au, Phone: 1800 274 276

Marketing authorization dates and numbers

14/10/1993

Drugs

Drug	Countries
SPIRACTIN	Australia, New Zealand, South Africa

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